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Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048776
Recruitment Status : Completed
First Posted : November 11, 2002
Last Update Posted : July 19, 2005
Information provided by:
Otsuka America Pharmaceutical

Brief Summary:
Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud’s are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynaud’s episodes in juvenile patients.

Condition or disease Intervention/treatment Phase
Raynaud's Disease Drug: Pletal Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 2001
Study Completion Date : June 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 5 to 16 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048776

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United States, Alaska
Advanced Medical Clinical Therapeutics
Anchorage, Alaska, United States, 99508
United States, California
Advanced Medical Research Institute
Fresno, California, United States, 93710
Madera Family Medical Group
Madera, California, United States, 93637
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Illinois
LaRabida Children's Hospital
Chicago, Illinois, United States, 60649
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis University Health Sciences Center
St. Louis, Missouri, United States, 63104
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Asthma & Allergy Research Center
Newark, New Jersey, United States, 07103
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Monarch Research Associates
Norfolk, Virginia, United States, 23510
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Otsuka America Pharmaceutical

Layout table for additonal information Identifier: NCT00048776     History of Changes
Other Study ID Numbers: 21-01-336
First Posted: November 11, 2002    Key Record Dates
Last Update Posted: July 19, 2005
Last Verified: July 2005
Keywords provided by Otsuka America Pharmaceutical:
Secondary Raynaud's
mixed connective tissue disease
Additional relevant MeSH terms:
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Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors